A Single-Center Study of RO5508887 in Healthy Volunteers

Roche

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteer

Treatments: Drug: RO5508887; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01664143

2012-000280-24 (EudraCT Number)

WP28102

Details and patient eligibility

About

This single-center, randomized, double-blind, placebo-controlled study will evaluate the safety, pharmacokinetics and pharmacodynamics of RO5508887 in healthy volunteers. Volunteers will receive multiple-ascending doses of RO5508887 or matching placebo. The anticipated time on study treatment is 14 days.

Enrollment: 36 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Adult healthy volunteers, >/=18 years of age
• Body mass index (BMI) between 18 and 30 kg/m2 inclusive
• Use of adequate contraception methods or surgically sterile

Exclusion criteria

• Evidence of active or chronic disease
• Regular consumption of drugs of abuse
• Regular smoker (>5 cigarettes per day)
• Infection with human immunodeficiency virus (HIV), hepatitis B (HBV) or hepatitis C (HCV)
• History of significant allergic reactions
• Abnormal blood pressure
• Clinical significant abnormalities (e.g., cardiovascular, laboratory values)

Trial design

36 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo

RO5508887

Experimental group

Treatment:

Drug: RO5508887